Feasibility Study of Laparoscopy-assisted D2 Distal Gastrectomy to Treat Advanced Gastric Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2016-12-31

Brief Summary

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The purpose of this study is to evaluate the oncological feasibility of laparoscopy-assisted distal gastrectomy with D2 lymph node dissection for advanced gastric cancer.

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Detailed Description

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To test oncological feasibility, compliance of nodal dissection was selected as a primary end point. When there are more than two missing nodal station(no lymph nodes in dissected area), it is defined as a non-compliant nodal dissection. Other secondary outcomes will be supplementary to evaluate feasibility of D2 dissection.

Conditions

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Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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open distal gastrectomy

open distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer

Group Type ACTIVE_COMPARATOR

open distal gastrectomy

Intervention Type PROCEDURE

open distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer

laparoscopy assisted distal gastrectomy

laparoscopy assisted distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer

Group Type EXPERIMENTAL

laparoscopy assisted distal gastrectomy

Intervention Type PROCEDURE

laparoscopy assisted distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer

Interventions

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laparoscopy assisted distal gastrectomy

laparoscopy assisted distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer

Intervention Type PROCEDURE

open distal gastrectomy

open distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer

Intervention Type PROCEDURE

Other Intervention Names

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LADG ODG

Eligibility Criteria

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Inclusion Criteria

* histologically proven primary gastric adenocarcinoma
* T2 or T3 or T4a, N0 or N1 or N2 or N3a (AJCC 7th), which is assessed by computed tomography (CT) scan - mid 1/3 or low 1/3 location
* No evidence of other distant metastasis
* not stump carcinoma,(vi) aged 20-80 year old
* performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
* no prior treatment of chemotherapy or radiation therapy against any other malignancies, and no prior treatment for gastric cancer including endoscopic mucosal resection
* adequate organ functions defined as indicated below:

* WBC 3000/mm3, WBC 12 000/mm3
* Hb 8.0 g/dl without any transfusion 2 weeks before enrollment
* Plt 100 000/mm3
* AST 100 IU/l
* ALT 100 IU/l
* T.Bil 2.0 mg/dl
* written informed consent

Exclusion Criteria

* active double cancer (synchronous double cancer and metachronous double cancer within five disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer)
* pregnant or breast-feeding women
* severe mental disorder
* systemic administration of corticosteroids
* unstable angina or myocardial infarction within 6 months of the trial
* unstable hypertension
* severe respiratory disease requiring continuous oxygen therapy
* previous upper abdominal surgery except laparoscopic cholecystectomy

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No